510(k) · Cleared
ClearedKaplan-Simpson Infusasleeve Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Localmed, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Apr 19, 1995 after a 68-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Apr 19, 1995
- Review
- 68 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK950615 Kaplan-Simpson Infusasleeve CatheterLocalmed, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK952317 Kaplan-Simpson InfusaSleeve II CatheterLocalmed, Inc. · 1995
- Descendant · 2 generations on · 0 of its ownK983039 Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set…Schneider/Namic · 1999
- Descendant · cites it directly · 0 of its ownK961294 Scimed Dispatch Gold Coronary CatheterScimed Life Systems, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K952317Kaplan-Simpson InfusaSleeve II CatheterLocalmed, Inc. · 1995 · cites it directly1descendant
- K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic · 1999 · 2 generations on0descendants
- K961294Scimed Dispatch Gold Coronary CatheterScimed Life Systems, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950615 | Kaplan-Simpson Infusasleeve Catheter | Localmed, Inc. | 1995 | — |
| +1 | K952317 | Kaplan-Simpson InfusaSleeve II Catheter | Localmed, Inc. | 1995 | — |
| +2 | K983039 | Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee… | Schneider/Namic | 1999 | — |
| +1 | K961294 | Scimed Dispatch Gold Coronary Catheter | Scimed Life Systems, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEY device
- #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K952317 (Localmed, Inc., 1995) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The InfusaSleeve is intended to infuse fluids such as heparanized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K950615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950615: Kaplan-Simpson Infusasleeve Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950615
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026